Emerging Indications for Therapeutic Antibodies

 

Significant scientific advances in the fields of immunology and protein science are driving the development of biotherapeutic drugs in a growing range of therapeutic areas beyond oncology. These advances are driving the identification of new and unique targets, new approaches to developing biotherapeutics for unserved medical needs, methods of binding to illusive targets and translational science for patient stratification and drug development for niche indications. The PEGS Emerging Indications for Therapeutic Antibodies conference provides a forum for research organizations with diverse portfolios to explore new science and technology in the development of a next generation of safe and effective therapeutics in an important set of emerging indications.

Final Agenda

SUNDAY, APRIL 8

Recommended Short Course(s)*

SC2: Translational Biotherapeutic Development Strategies Part 1: Discovery, Molecular Assessment and Early Stage Development - Detailed Agenda

Juan Carlos Almagro, PhD, Founder and Director, GlobalBio, Inc.

Zhiqiang An, PhD, Professor, Chemistry; Director, Texas Therapeutics Institute, University of Texas Health Science Center at Houston

Gadi Bornstein, PhD, Senior Director, Biologics Discovery, TESARO, Inc.

SC7: Translational Biotherapeutic Development Strategies Part 2: Analytical and Clinical Considerations - Detailed Agenda

Zhiqiang An, PhD, Professor, Chemistry; Director, Texas Therapeutics Institute, University of Texas Health Science Center at Houston

Scott L. Klakamp, PhD, Senior Director & Head, Biophysics, Biologics Development Sciences, Janssen BioTherapeutics

Liming Liu, PhD, Senior Principal Scientist, Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM), Merck Research Laboratories

An Song, PhD, Senior Vice President, Development Sciences, Immune-Onc Therapeutics, Inc.

 

*Separate registration required.

MONDAY, APRIL 8

7:00 am Registration (Commonwealth Hall) and Morning Coffee (Harbor Level)

GPCR AND ION CHANNEL TARGETS

Cambridge complex

8:30 Chairperson’s Opening Remarks

Catherine Hutchings, PhD, Independent Consultant, United Kingdom

8:40 Synthetic Antibody Fragments as Sensors and Modulators of GPCR Activation and Signaling

Shukla_ArunArun Shukla, PhD, Chair, Professor and EMBO Young Investigator Intermediate Fellow, Wellcome Trust DBT India Alliance, Indian Institute of Technology, India

G protein-coupled receptors (GPCRs) constitute the largest class of cell surface receptors and they are targeted by majority of currently prescribed medicines. We have developed and characterized a series of synthetic antibody fragments through Phage Display technology platform that can report GPCR activation with spatio-temporal resolution and modulate selective functions in cellular context.

9:10 Production of Inhibitory Antibody Against Claudin-5 using Engineered Membrane Protein Antigens

Takeda_HiroyukiHiroyuki Takeda, Ph.D., Associate Professor and Principal Investigator, Division of Protea-Drug-Discovery Sciences, Proteo-Science Center, Ehime University, Japan

The production of antibodies against extracellular regions (ECR) of membrane proteins is notably difficult because of the low productivity and immunogenicity of membrane proteins. We overcome these problems by using protein engineering and cell-free protein production technology. Immunization of engineered claudin-5 (CLDN-5) ECR antigens induced CLDN-5 ECR-binding antibodies with a high rate. Five monoclonal antibodies against CLDN-5 ECR were produced from immunized mice, and one clone successfully inhibited CLDN-5-dependent tight junctions.

9:40 Pipeline Update on GPCR and Ion Channel Antibodies

Hutchings_CathCatherine Hutchings, PhD, Independent Consultant, United Kingdom

G protein-coupled receptors (GPCRs) and ion channels represent some of the most important target classes for therapeutic drug discovery across a wide range of diseases. The progress made by antibody-based therapeutics directed to these target classes will be reviewed outlining the breadth and diversity of antibody molecules, target opportunities in R&D and the clinical pipeline, including recent development to the expansion of opportunities afforded by next-generation modalities.

10:10 Networking Coffee Break (Harbor & Mezzanine Level)

AUTOIMMUNITY AND INFLAMMATION

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10:50 Amplifying Antibody Function with Nanomaterials for Inflammation and Autoimmune Therapy

Fahmy_TarekTarek Fahmy, PhD, Associate Professor of Biomedical Engineering and Immunobiology, Yale University

Antibody therapy (armed or unarmed) as a “magic bullet” dates back to Paul Ehlirch in the late 1800’s. To date, the “magic bullet” continues to be challenging to implement in a general manner for treatment of inflammation and autoimmune disease remission. I’ll discuss a paradigm-shift in amplifying antibody function using small packages called, “nanoparticles” loaded with drugs or biologics and targeted to regulatory immunity. The methodology overcomes several limitations with conventional antibody therapy.

11:20 Novel Anti-CD20 Antibodies for Treating Autoimmune Disease and Hematologic Malignancies

Misorin_AlexeyAlexey Misorin, Senior Research Associate, Antibody Discovery, BIOCAD, Russian Federation

We have developed monoclonal antibodies against CD20 for treating autoimmune diseases – BCD-132, and for treating hematologic malignancies – BCD-171. BCD-132 and BCD-171 interact with extracellular part of CD20 antigen with nanomolar affinity and demonstrate desirable properties in vitro. We will present results from a phase I study of BCD132 in which we evaluated pharmacokinetics, pharmacodynamics, safety and immunogenicity of our antibodies.

11:50 KEYNOTE PRESENTATION: Lessons Learned from Humira

Salfeld_JochenJochen Salfeld, PhD, Vice President, Global Biologics; Distinguished Research Fellow, AbbVie

The presentation will focus on the evolution of therapeutic Anti-TNF approaches, the history of adalimumab and will start to answer the question how to explain some of the apparent clinical differences between the Anti-TNF agents in clinical use today. In this context the learnings about TNF biology and the mechanism of action of TNF antagonists will be discussed and how those learnings impact the development of novel therapeutics.

TetraGenetics 12:20 pm A Multiplatform Strategy for the Discovery of Modulating Antibodies Against Ion Channel Targets

Bisharyan_YelenaYelena Bisharyan, Director, External Alliances, Tetragenetics, Inc.

Identifying antibodies that block ion channels is a challenging endeavor exacerbated by difficulties in producing recombinant ion channels in amounts that support drug discovery programs. We have developed a strategy to address this challenge by combining high-level expression of these proteins with immunization of diverse species and unique screening tools.

Sanguine_Biosciences 12:35 Longitudinal, Event-Based, Same-Day Sample Collection: The Implications for Biomarker Development

Neman_BrianBrian Neman, CEO, Sanguine Biosciences

Sanguine partners with patients and leverages their health data to accelerate your research for their condition. By working together with patients, directly, Sanguine is able to perform home visits, and to easily retrieve medical records, on their behalf. 500+ completed studies. 20/40 top pharma. 30,000+ patients.

Abzena 12:50 Luncheon Presentation I: Developability: Evaluating Specificity, Immunogenicity, Functionality & Manufacturability For Lead Candidate Selection

Bunce_CampbellCampbell Bunce, Senior Vice President, Scientific Operations, Abzena

Understand the latest series of in silico computational models, analytics, in vitro and ex vivo experiments used in developability assessment. Characterise a molecules Specificity, Immunogenicity, Safety, Functionality and Manufacturability. Data generated informs sequence, structural, formulation and process refinements to select the best candidate for manufacture.

GenScript-CRO 1:20 Luncheon Presentation II: Development of Active and Passive Immunization Strategies for Preventing HIV Infection

Mauricio Martins, PhD, Assistant Professor, Biology, University of Miami

Despite improvements in prevention strategies and antiretroviral therapy coverage, thousands of new HIV infections are still occurring every day, underscoring the need for effective anti-HIV immune interventions. Here I will describe how my laboratory has been developing and testing immunization strategies against HIV in rhesus macaques (RMs). In the first part of the talk, I will show how we used a new vaccine modality to elicit protective immunity against a highly pathogenic simian immunodeficiency virus (SIV) molecular clone. This vaccine regimen consisted of DNA plasmids delivered by intramuscular electroporation and replication-competent forms of rhesus monkey rhadinovirus (RRV)–a herpesvirus that establishes persistent infection in RMs. In the second part of the talk, I will go over our plans to gene therapy to prevent mother-to-child transmission (MTCT) of HIV. Specifically, we will use adeno-associated virus (AAV) vectors to transfer genes encoding HIV-specific broadly-reactive neutralizing monoclonal antibodies (bnMAbs) newborn RMs. AAV vectors have emerged as safe and versatile gene therapy tools that can transduce both dividing and non-dividing cells. Given the long lifespan of muscle cells (average: 15 years), skeletal muscle is a preferred tissue for AAV-mediated gene transfer. Thus, a single intramuscular injection of AAV/bnMAb vectors at birth might result in long-term production of bnMAbs for years, possibly decades. Achieving this outcome in infants would dramatically simplify efforts to prevent MTCT of HIV. We hope that the HIV immunization approaches described here will provide new insights into how to generate persistent immunity against HIV.

 

1:50 Session Break

2:20 Problem-Solving Breakout Discussions - Click here for details (Commonwealth Hall)

3:20 Networking Refreshment Break (Harbor & Mezzanine Level)

PLENARY KEYNOTE SESSION

amphitheater & Harborview ballroom

4:00 Chairperson’s Remarks

Rakesh Dixit, PhD, DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, Translational Sciences, MedImmune

PLENARY KEYNOTE SPEAKER

4:10 Vision for How Immunotherapy Will Shape Future of Cancer Care

Leena Gandhi, MD, PhD, Vice President, Immuno-Oncology Medical Development, Lilly Oncology

Immunotherapy is considered by many as a pillar of cancer care today, but in many ways we have only scratched the surface. Our knowledge and understanding of the complexities of immunotherapy and its mechanisms continue to evolve. The future of cancer care will be defined by our ability to systematically identify and implement opportunities for combination therapy to improve and standardize patient response.

YOUNG SCIENTIST KEYNOTE

4:55 The Lassa Virus Glycoprotein: Stopping a Moving Target

keynote-headshot-hastie-400x400Kathryn Hastie, PhD, Staff Scientist, Immunology and Microbiology, The Scripps Research Institute

Lassa virus causes ~5000 deaths from viral hemorrhagic fever every year in West Africa. The trimeric surface glycoprotein, termed GPC, is critical for infection, is the target for neutralizing antibodies, and a major component of vaccines. Structural analysis of Lassa GPC bound to antibodies from human survivors reveals a major Achilles heel for the virus and provides the needed template for development of immunotherapeutics and improved vaccines.

5:40 Welcome Reception in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

7:15 End of Day

TUESDAY, APRIL 9

8:00 am Registration (Commonwealth Hall) and Morning Coffee (Harbor Level)

INNOVATIVE MOLECULAR AND PRODUCT FORMATS

cambridge Complex

8:25 Chairperson’s Remarks

Ahuva Nissim, PhD, Professor, Antibody and Therapeutic Engineering, Biochemical Pharmacology, Queen Mary University, United Kingdom

8:30 Direct Targeting Cytosolic Proteins by IgG-Format Antibody

Kim_Yong-SungYong Sung Kim, PhD, Professor, Molecular Science & Technology, Ajou University, Korea

Our group recently developed a platform technology of a cytosol-penetrating antibody (cytotransmab), which in the IgG format can reach the cytosolic space of living cells owing to its endosomal escaping ability after receptor-mediated endocytosis. Based on the cytotransmab technology, we have engineered a human IgG1 format antibody, named iMab, which specifically internalizes into the cytosol of tumor cells and then selectively binds to targeted cytosolic proteins, including oncogenic Ras mutants.

9:00 Targeting Microvesicles Loaded with Drugs to Arthritic Joints Using Antibodies Specific to Arthritic Cartilage

Nissim_AhuvaAhuva Nissim, PhD, Professor, Antibody and Therapeutic Engineering, Biochemical Pharmacology, Queen Mary University, United Kingdom

Microvesicles (MV) are extracellular vesicles released from the plasma membrane of cells. We loaded MV with antibody specific to damaged arthritic cartilage (anti-ROS-CII). After assessing incorporation and in vitro functional validation, in vivo localization and treatment experiments using mouse model of arthritis were successfully performed. MV targeted by anti-ROS-CII loaded with combined treatment significantly accelerated resolution of inflammation. Thus, targeted MV may be developed as a ‘magic bullet’ to safely treat diseases.

9:30 V565, an Oral Anti-TNFα Domain Antibody for IBD

Carlton_TimTim Carlton, PhD, Associate Director, Research, VHsquared, United Kingdom

V565 is an anti-TNFα domain antibody for oral administration in IBD patients, derived from a llama single domain antibody and engineered for intestinal protease resistance. Ex vivo biopsy studies, measuring changes in phosphoprotein levels, and oral dosing studies in man demonstrate that V565 is highly potent, stable throughout the intestine and able to penetrate the disrupted colonic mucosa and neutralize membrane and soluble TNFα at the site of active disease.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

INFECTIOUS DISEASES

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10:50 Antibody Responses to Influenza in Context

Wilson_PatrickPatrick C. Wilson, PhD, Professor, Medicine & Rheumatology, Knapp Center for Lupus and Immunology Research, Committee on Immunology, University of Chicago

Influenza infections are a leading cause of death and illness. Current vaccines to influenza are insufficient because of changes in viral antigenicity. Recent work will be discussed on the characterization of human B cell and antibody responses to influenza. This work has led to key insights that should allow improvements to influenza vaccines and to identify monoclonal antibodies that could be used therapeutically.

11:20 Antibody-Antibiotic Conjugate against Staphylococcus Aureus: Mechanism and Modulation of Activity

Hazenbos_WouterWouter Hazenbos, PhD, Scientist, Infectious Diseases, Genentech

Complicated Staphylococcus aureus infections can be difficult to treat, as bacteria may reside in intracellular reservoirs, limiting antibiotic access. We generated an antibody-antibiotic conjugate, comprising an antibody binding S. aureus, conjugated to a rifamycin-analog through a cathepsin-cleavable linker. This molecule kills S. aureus inside host cells, and is superior to standard antibiotics in mouse infection. Current work focuses on MOA; new technology to enhance activity; applicability to other pathogens.

11:50 Structure-Based Approaches for the Discovery of Potent Antibodies against Malaria Antigens

Julien_Jean-_PhilippeJean- Philippe Julien, PhD, Canada Research Chair in Structural Immunology, The Hospital for Sick Children Research Institute

Reverse vaccinology holds promise to design effective immunogens for the development of malaria vaccines. This concept is based on interrogating B cell repertoires to identify inhibiting antibodies that will guide immunogen design. Our research focuses on characterizing protective antibodies of high potency against malaria antigens at the bottlenecks of transmission between the mosquito vector and human host. These studies also have implications for the development of antibody interventions against malaria.

12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on your Own

1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

OTHER EMERGING INDICATIONS

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2:00 Chairperson’s Remarks

Anthony Shock, PhD, Director, Immunology Research, UCB, United Kingdom

2:05 Anti-Cytokine Therapy for Atherosclerosis

Ridker_PaulPaul M. Ridker, MD, MPH, Eugene Braunwald Professor of Medicine, Harvard Medical School; Director, Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital

Recently, the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) has demonstrated that specific targeting of interleukin-1beta can significantly lower cardiovascular event rates with no effect on cholesterol or blood pressure. Moreover, the magnitude of clinical benefit was related to the robustness of inflammation inhibition. Thus, we now have proof of principle for the inflammation hypothesis of atherothrombisis and a signal for multiple new treatment targets.

2:35 Targeting FcRn in IgG Autoantibody-Driven Diseases

Shock_AnothonyAnthony Shock, PhD, Director, Immunology Research, UCB, United Kingdom

The neonatal Fc receptor, FcRn is responsible for rescuing IgG from lysosomal degradation and is responsible for the long half-life of this protein in vivo, but FcRn is also responsible for recycling pathogenic IgG autoantibodies. Rozanolixizumab is a high affinity IgG4P mAb targeting FcRn, developed to specifically inhibit the recycling of IgG and is demonstrating clinical efficacy in patients with IgG autoantibody-driven diseases.

3:05 MutaMap®, a Mutational Activity Map for Optimum Protein Design

Knowlton_EmileeEmilee Knowlton, PhD, Immunology, Sales Specialist, Sales, ProImmune Inc.

MutaMap® is an in vitro assay system that helps explore the effect of substituting each amino acid in at each position in a protein sequence one by one with all 19 possible substitutions and find out the effect on protein activity. MutaMap® allows you to make informed protein engineering decisions for a range of key developability objectives, including; Improving activity/affinity, de-immunization, altering cross reactivity, improving humanization and prolonging half-life of your protein.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing (Commonwealth Hall)

4:25 Completing the Immunity Cycle by Developing Myeloid Immunotherapies

Novobrantseva_TatianaTatiana Novobrantseva, PhD, Co-Founder, Head of Research and Development, Verseau Therapeutics

Macrophages/DCs are biologically optimized to either induce or suppress an immune response. Targeting pro-tumorigenic macrophages has been repeatedly identified as a very important next step of development for the field of immuno-oncology. Similarly, myeloid cell suppression has been long realized to be fueling the vicious cycle of the autoimmune disease. The talk will describe Verseau Therapeutics’ approaches to tweaking myeloid cell functionality in human disease.

4:55 Antagonistic Antibodies Used to Establish the Key Role for IL-13 Signaling Via the Type 2 IL-4 Receptor in Experimental Atopic Dermatitis

Benhar_ItaiItai Benhar, PhD, Professor, Molecular Cell Biology and Biotechnology. Tel-Aviv University

IL-13 and IL-4 are potent mediators of type 2-associated inflammation such as asthma and atopic dermatitis (AD) and share a receptor subunit, IL-13Ra1 which is part of IL-4R. The role of the type 2 IL-4R in AD remains to be defined. We show that oxazolone-induced AD in mice is dependent on the type 2 IL-4R and targeting of the type 2 IL-4R using an IL-13Ra1-neutralizing antibody alleviates oxazolone-induced AD.

5:25 End of Emerging Indications for Therapeutic Antibodies

5:30 Registration for Dinner Short Courses (Commonwealth Hall)


Recommended Dinner Short Course*

SC11: Developability of Bispecific Antibodies: Formats and Applications

Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics

 

*Separate registration required.

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